DIA 48th Annual Meeting
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How to Be Prepared for Shifting Regulations on Combination Products
Track : Track 14: Clinical Safety and Pharmacovigilance
Program Code: 320
Date: Wednesday, June 27, 2012
Time: 8:00 AM to 9:30 AM  EST
CHAIR :
 Ann Tunstall, SciLucent LLC, United States
PRESENTER (S):
Ann Tunstall, Managing Consultant, SciLucent LLC
Mary Mease, Quintiles, Inc
 Ajay Keshava, WCI Consulting Limited, United States
Description
Regulations for combination products have remained in flux in recent times, which has affected the approach and execution of safety processes. This session will examine what re-tooling is required by companies in light of new regulations.

Learning Objectives:
Discuss clear ideas on how to remodel industry strategy and tactics away from a core competency
Discuss updated regulations and the potential need for reclassification of combination products.